VELCADE Approved Across all Disease Stages

Janssen-Cilag / Ortho Biotech, today announced the European Commission's approval of VELCADE in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma (MM) who are not eligible for high-dose chemotherapy with bone marrow transplant.

In more than 87 countries worldwide, VELCADE monotherapy had already been approved for the treatment of relapsed and / or refractory MM in patients who have received at least one prior therapy.
"VELCADE has already made an important contribution for patients with multiple myeloma at first relapse," said Professor Jesus San Miguel, M.D., University of Salamanca in Spain, the principal investigator for the VISTA trial. "The marketing authorisation from the EMEA is encouraging as it suggests that more patients may benefit from earlier treatment."

The frontline approval is based on phase III results from the VISTA trial, recently published in the New England Journal of Medicine, which demonstrated statistically superior results across all efficacy endpoints compared to melphalan and prednisone. In particular, complete response (CR) rates were similar to those that have been achieved in the transplant setting. VISTA stands for: VELCADE as Initial Standard Therapy in Multiple Myeloma.